Pronunciation:

trye-meth-a-DYE-one

Classifications:

Chemical—

Oxazolidinedione

Uses of This Medicine:

Trimethadione is used to control absence (petit mal) seizures in patients with epilepsy who have used other medicines that did not work well. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of trimethadione have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.

Older adults—

No information is available on the relationship of age to the effects of trimethadione in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ginkgo

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disorder, severe or
• Kidney disease, severe or
• Liver disease, severe—Should not be used in patients with these conditions.

• Depression, history of or
• Eye problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may chew this tablet or swallow it whole.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (chewable tablets):
  • For seizures:
    • Adults—0.9 to 2.4 grams (g) per day in 3 or 4 equally divided doses (eg, 300 to 600 milligrams [mg] tablet 3 or 4 times daily). Your doctor may increase your dose as needed.
    • Children—The dose is usually. 0.3 to 0.9 g per day in 3 or 4 equally divided doses.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

It is very important that your doctor check your and your child's progress closely while using this medicine to see if it is working properly and to allow for a change in the dose. Blood and urine tests may be needed to check for any unwanted effects.

Do not stop taking this medicine without first checking with your doctor. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Your doctor may want you or your child to slowly reduce the amount you are using before stopping completely.

Trimethadione may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause lupus-like and myasthenia-like symptoms. Check with your doctor right away if you or your child has droopy eyelids, rash on the cheeks or other parts of the body, sensitivity of the skin to sunlight, joint or muscle pain, chest pain, swelling of the feet, ankles, and legs, weakness of the arms or legs, trouble swallowing, speech problems, or swollen glands.

Tell your doctor right away if you or your child feels unusually weak, starts bruising easily, has bleeding gums or nosebleeds, seems to be sick more often, has a fever, swollen glands, or a sore throat that will not go away. These could be a signs of a serious problem with the number of blood cells in your body.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have a severe skin rash, blistering, peeling, or loosening of the skin, red skin lesions, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with trimethadione may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, other medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blisters, hives, or itching

blood in the urine or stools

blurred vision

changes in blood pressure

changes in vision, especially night blindness

chest pain

cloudy or dark urine

cough

cracks in the skin

decreased vision

diarrhea

difficulty in breathing, chewing, swallowing, or talking

double vision

drooping eyelids

fever with or without chills

general feeling of discomfort or illness

general feeling of tiredness or weakness

glare or snowy image caused by bright light

hair loss

headache

high fever

increased irritability

increased sensitivity of the eyes to sunlight

light-colored stools

loss of bladder control

loss of heat from the body

lower back or side pain

muscle or joint pain

muscle weakness

nausea

nosebleeds

painful or difficult urination

pale skin

personality changes

pinpoint red spots on the skin

red, irritated eyes

red, swollen skin

scaly skin

severe tiredness

skin rash

small red or purple spots on the skin

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swelling of the face, hands, legs, and feet

swollen, painful, or tender lymph glands in the neck, armpit, or groin

total body jerking

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal pain

vaginal bleeding

vomiting

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Loss of consciousness

shakiness and unsteady walk

unsteadiness, trembling, or other problems with muscle control or coordination

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dizziness or lightheadedness

drowsiness

feeling of constant movement of self or surroundings

hiccups

loss of appetite

sensation of spinning

stomach pain or distress

trouble sleeping

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.